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LBC-EVIDENCE
FORIMPROVED
DETECTION
OFHIGHGRADELESIONSTomasSlavikAnatomical
PathologistAmpath
Pretoria
Cytology
LaboratoryIntroduction
“
e1
l
cancer
through
labs’errors"Critical
scrutiny
of
cervical
cancer
screening
failuresfo
m
eding
5
years
(>80
%)-
false
negative
Paptest
(1
%)*=70%-sampling
issue
(cells
notcollected/transferred
onto
slide)二
30
%-interpretative
issue(abnormal
cells
present
butmissed
/misinterpreted)*McCrory
DCetal,AgencyforHealthCare
Policyand
Research,2019eirriueapswPapllono■a:c7rvi98uch
c2
NovissesJourntePapteWall
SSensitivityofasingleconventionalcervicalsmearisassessed
in
the
literature
at50
-60%Faheyetal2019Specificity
>95%AHC
E0100-0200002019paioaHnTdAaPubliUKNPRInitial
LBCstudies
0G'sS:LILB
e
ehc
wio
pi
at
e
inAs
more
studies
were
published,caseosarencren
coramatne
i
eluds,i
ys
dologyimilarmethonuostonceasveerimprnumconventionalcytologymanystudieshadshortcomings
(smallpatientnumbers,splitsample,comparisonofoutcomes,no
reference
standard)YearPrimary
AuthorJo
urnalType
of
Study#TPPTBiopsyEffect
on
HSILStatistical
Significance2003LimayeArch
Pathol
Lab
MedDirect-To-Vial166,384YesIncreased
173%p<0.0012003NICE
StudyReport
to
the
Dept
of
HealthDirect-To-Vial34,813YesIncreased
17%nostatistical
significance2002Scottish
StudyScottish
GroupCSP
SteeringReportDirect-To-Vial30,228YesIncreased
85%p<0.0012001Obwegeser
Acta
CytologyDirect-To-Vial997YesDecreased
15%notstatistically
different2001ClavelBr
JCancerDirect-To-Vial7,932YesIncreased
28%p<0.052000FerrisJFam
PractDirect-To-Vial992YesIncreased
119%p<0.0012000WeintraubDiagn
CytopatholDirect-To-Vial39,864YesIncreased
244%p<0.00119991999YeohDiaz-RosarioHongArchKongPatholMed」Lab
MedDirect-To-VialDirect-To-Vial16,541YesIncreasedIncreased28%103%p<0.0156,339Yesp<0.0011998GuidosDiagn
CytopatholDirect-To-Vial9,583YesIncreased
233%p<0.0011998PapilloActa
CytologyDirect-To-Vial8,541YesIncreased
55%p<0.0012001MonsonegoBr
JCancerSplit
Sample5,428YesIncreased
18%noPvalue
calculated1999HutchinsonCancer
CytopatholSplit
Sample8,636YesIncreased
19%p<0.0011999Ro
bertsMed
JAustSplit
Sample85,732YesIncreased
16%noPvalue
calculated1999WangJ
Formos
Med
AssocSplit
Sample972YesIncreased
31%p<0.0062001BernsteinAm
JObstet
GynecolMeta-analysis221.864Meta
Increased137%tbdDetectionofHighGrade
Disease(HSIL)International
Clinical
DataDataforFDAapproval
(directtovial)2019:ThinPrep(Cytyc)-59%increasedHGSIL+detection2019:Surepath(Tripath)-64
%increasedHGSIL+detectionWeighted
average4
laboratoriesTotal
30,228
in
6
monthsConv%ThinPrep%Unsatisfactory7.31.84Borderline(~ASC
US)3.983.68Mild
dyskaryosis
(LSIL)1.12.12Moderate
+severedyskaryosis
(HSIL)1.12.03Scottish
LBCPilot
Results(2019)PPV
79.5-87.5%87408
Conventional(%)2019-201978064
ThinPrep(%)2019-2019Unsatisfactory13.61.9Negative80.991.7Borderline2.52.6Mild2.02.3
+15%Moderate0.60.8
+33%Severe0.40.6
+50%Others0.10.1EdlinburghLaterstudies(secondaryresearch,*
Austin
M,Ramzyl.ActaCytol2019;42:178-84*
Abulafia
Oetal.GynecolOncol2019:90:137-44Karnon
J
et
al.Health
TechnolAssess2019;8:iii,1-78systematicreviews,meta-analyses)i
i
)LGSIL
+%of7n1o6-1tectsedts,danncrepatiesignificantlyeswith
79366Cdion
LB23
stu24studies;10withreferencestandard(21752
patients)
e
iBfiCc
ithya
7o
rall
increased
sensitivity(8
%)cLpdsweansh2largest
studies(88569
and
74573
patients)found79-96
%increased
HGSIL+detection,aggregatesensitivity
increased
12%withLBCBUT...l
f
udies(onlyConclusionsofhigh,mediumand
lowqualityInadequacycriteriain
studies
differed)tssrele45tabut
ofacceofdiesno.oultlity
ssmaayigh
quremel5
hExtstudiesconflicting
(e.g.LGSILdetectionincreasedinallqualitystudies,HGSILdetection
ii
/low
quality
studies
and
ineuindependentstudincreased
in
medDavey
Eetal,BMJ,2019;335;31consideredtheirprevious
Lancet
LBCstudy=
"inconclusive"with
LBCand
imager-fewer
unsatisysldes
than
CC-improved
detection
of
SIL
(2,8vs2,2%)detects
1,29more
HGSIL/
1000casesscreenedthanCCRenshaw
Aet
al.Arch
Pathol
Lab
Med2019;128:17-22
i
a
o
886LBC)LBCassociatedwithsignificantlylowererror0n2i89815
CC
andarisonProgramgyomloCCytoralorinbgavaerlCervCAPratesindiagnosingpathology
when
comparedwith
CCGovernment
Health
Reviews/TechnologyAssessmentsliit
eHRe
r
(
)ical
Advisory6
%increase
in
biopsy-proven
highgradelesionswith
LBC
cehn/
y
e,
0lt9C)are
Policy
andUK-NICE(2019,2019)-KarnonJet
al.1hPrHfaAeSohplteaenommustraLBCshows"significant
improvement
insensitivity"overCC出
lsrOunllyAsswenseInCsvsnleanser
e
i
5
u
lb
l
o
h
i
r
Lrate
Denmark(Kirschner
B
et
al.Cytopathol2019;17:187-94)Sweden
(Strander
B
etal.Cancer
Cytopathol2019;111:285-91)Cana
ynt
gsstu
s
o
o,4g
r
l
it(
t
4
%u)b9ive20nstheaseeHonms
i%ie6lBChnLcedins
in
20for
Drucaeepgsp4Ass811ianeasedHGSIincrsedofeanceincelyidntvaecer
nosigniftdgeaniestialudanttsst
al=subs),ie%ud8st(rtnoohctcodettwo13484
patients(direct
to
vial)=42
%increase
in
high
grade
lesionsi
efnotm(d
al)=23,3
%increase
in
“cellsyicvnonat
tallgirecrsouspatipic513s6u6s1CC
ONLYCC+LBC30905
cases49041
casesAmpathPretoriaCytopathology
Laboratory-
HGSIL
=1,2
%-HGSIL=1,6%(33
%increase)CONCLUSIONONhueseid
le
uoo6oljeleqAueeneueMoaS3
人esmellleluelod?neueinelei!lsiul
seoaS3
人ou
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